| CTRI Number |
CTRI/2025/12/099266 [Registered on: 16/12/2025] Trial Registered Prospectively |
| Last Modified On: |
15/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
IMMEDIATE EFFECTS OF DIFFERENT ANKLE EXERCISE ON ELECTROMYOGRAPHIC PARAMETERS IN INDIVIDUALS WITH LONG TERM ANKLE INSTABILITY |
|
Scientific Title of Study
|
Immediate Effects oF Structured Ankle Training Strategies on Electromyographic Parameters in Idividuals with Chronic Ankle Instability: A comparative study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ISMAIL HAZIM |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
TEJASVINI PHYSIOTHERAPY COLLEGE |
| Address |
Tejasvini Physiotherapy College, Opp Anantha Padmanabha Temple, Kudupu
Dakshina Kannada
KARNATAKA
575028
India |
| Phone |
9743368634 |
| Fax |
|
| Email |
ismailhazim317@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ISMAIL HAZIM |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
TEJASVINI PHYSIOTHERAPY COLLEGE |
| Address |
Tejasvini Physiotherapy College, Opp Anantha Padmanabha Temple, Kudupu
Dakshina Kannada
KARNATAKA
575028
India |
| Phone |
9743368634 |
| Fax |
|
| Email |
ismailhazim317@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ISMAIL HAZIM |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
TEJASVINI PHYSIOTHERAPY COLLEGE |
| Address |
Tejasvini Physiotherapy College, Opp Anantha Padmanabha Temple, Kudupu
Dakshina Kannada
KARNATAKA
575028
India |
| Phone |
9743368634 |
| Fax |
|
| Email |
ismailhazim317@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tejasvini Physiotherapy College, Kudupu, Mangalore, 575028 |
|
|
Primary Sponsor
|
| Name |
Ismail Hazim |
| Address |
Post Graduate Student, Tejasvini Physiotherapy College, Kudupu, Mangalore, Karnataka, India, 575028 |
| Type of Sponsor |
Other [Self Funded Study] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr RIYAS BASHEER K B |
Tejasvini Physiotherapy College |
EMG NCV ROOM, Gound Floor, TEJASVINI PHYSIOTHERAPY COLLEGE,
OPP ANANTHA PADMANHABA TEMPLE
KUDUPU
Dakshina Kannada
KARNATAKA |
9995092825
riyas2423@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M253||Other instability of joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cognitive Training |
Comparator: Undergoes Dual-task exercises involving balance tasks combined with cognitive tasks with 10 reps in single session
Cognitive challenges in single leg stance in 10 sec wit 10 reps (Recite the alphabet backwards, Spell her name backwards, Name animals from India)
|
| Intervention |
Ebbets Foot Drills training |
Intervention: Ebbets foot drills-The subject was made to do the drills on a plain surface. The therapist stood at the side to supervise the treatment. The foot drills consist of 6 types of foot positions [Toe in walk, Toe out walk, Inversion walk, Eversion walk, Toe walk, Heel walk, and the patient has to walk for 25 meters in each of these positions. |
| Comparator Agent |
Proprioception Training |
Comparator: Receives Balance exercises on unstable surfaces (e.g., wobble boards), with 10
reps in single session
Wobbleboard training:
The patient was made to do four types of exercises on the wobble board and
the patient has to do these exercises for 10 repetitions in each sides.
The therapist stood at the side to supervise the treatment [Side to side, Front and back, Clockwise, Anticlockwise] |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with chronic ankle instability.
Cumberland Ankle Instability Tool (CAIT) score less than or equal to 24 or 25.
Age between 18 to 25 college students.
|
|
| ExclusionCriteria |
| Details |
Previous history of fracture or surgery in the lower extremity, history of any neuro logical or cardio-respiratory diseases.
Previous history of any self-reported musculoskeletal or neurovascular injuries.
Disorders in the lower extremity within the previous 6 months other than lateral ankle sprain.
Participants who had initiated gym training recently were excluded from the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
EMG parameters includes: MUAP (motor unit action potential), RMS (Root mean
square), SP (Spike potential), SEA (Spontaneous electrical activity), Onset,
Amplitude. |
pre and post |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Ankle instability (Foot and ankle ability measure & Cumberland ankle instability
Tool.
Ankle ROM: Measuring by using Goniometry.
- Ankle muscle strength: Assessing by using Hand-Held Dynamometry |
pre and post |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study will Provide evidence-based insights into different training modalities. Guide therapists, clinicians, and sports practitioners in selecting optimal rehabilitation techniques. Contribute to enhancing athletic performance and reducing injury recurrence. |